Sacituzumab Govitecan for Breast Cancer
(ASCENT-07 Trial)

Recruiting in Palo Alto (17 mi)

+288 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Eligibility Criteria

This trial is for adults with HR+/HER2- metastatic breast cancer who've had disease progression despite endocrine therapy. They must have a sample of tumor tissue available, not be candidates for further endocrine treatment, and have adequate organ function. HIV-positive participants need controlled infection on ART. Participants must agree to use contraception and should not be eligible for curative intent therapy or have received certain prior treatments.

Inclusion Criteria

My breast cancer is hormone receptor positive and has spread, confirmed by a recent biopsy.

My organs are functioning well.

My cancer returned within 24 months while on hormone therapy, counting as one treatment line.

+13 more

Exclusion Criteria

I haven't taken any experimental estrogen-blocking drugs in the last 14 days.

I am HIV positive with a history of Kaposi sarcoma or Multicentric Castleman Disease.

My breast cancer is advanced but considered treatable with the intent to cure.

+8 more

Participant Groups

The study tests if Sacituzumab Govitecan (SG) extends the time without cancer growth in patients with HR+/HER2- metastatic breast cancer compared to standard treatments like Paclitaxel, Nab-paclitaxel, or Capecitabine. It measures how long patients live without their disease getting worse.

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention

Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.

Group II: Treatment of Physician's Choice (TPC)Active Control3 Interventions

Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: * paclitaxel 80 mg/m\^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * nab-Paclitaxel 100 mg/m\^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * capecitabine at 1000-1250 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.

Sacituzumab Govitecan-hziy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Trodelvy for:

Metastatic triple-negative breast cancer
Metastatic urothelial cancer
Metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer

🇪🇺 Approved in European Union as Trodelvy for: